Cost-Effectiveness of Intensive Trauma-Focused Treatment versus Spaced Trauma-Focused Treatment as First-Line Treatment for Post-Traumatic Stress Disorder in Adults With Multiple Trauma Exposure: Randomized Controlled Trial

Cost-Effectiveness of Intensive Trauma-Focused Treatment versus Spaced Trauma-Focused Treatment as First-Line Treatment for Post-Traumatic Stress Disorder in Adults With Multiple Trauma Exposure: Randomized Controlled Trial - FLIP-IT study (First-Line Intervention for PTSD - Intensive Treatment)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56960

Enrollment

186

Registered

2024-02-26

Start date

2024-11-18

Completion date

Unknown

Last updated

2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic stress disorder PTSD

Interventions

The experimental group receives I-TFT, consisting of 2 50-min preparatory sessions

5 days of I-TFT (60-min Prolonged Exposure + 60-min Eye Movement Desensitization &amp

Reprocessing therapy) within two weeks

and 2 50-min follow-up sessions. The control group receives S-TFT consisting of 16 weekly, 50-min evidence-based S-TFT sessions (Prolonged Exposure, Eye Movement&nbsp

Desensitization &amp

Reprocessing therapy, Brief Eclectic Psychotherapy for PTSD, Narrative Exposure Therapy, or Imagery Rescripting). Both conditions have a total treatment duration of 800 minutes.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) 18 years or older; (2) PTSD diagnosis according to DSM-5 (CAPS-5);  (3) PTSD diagnosis based on >= 2 potentially traumatic events (PTEs);  (4) no prior treatment for PTSD (or less than 8 sessions); 

Exclusion criteria

Exclusion criteria: (1) current psychotic disorder, severe alcohol or substance use disorder, high suicidal intent (MINI-S for DSM-5) with a concrete suicide plan; severe aggressive behavior that poses danger for others; (2) insufficient command of the Dutch language to be able to complete the assessments.

Design outcomes

Primary

Measure	Time frame
The primary clinical outcome parameter is the difference in response pattern in terms of PTSD symptom severity on the clinical interview (CAPS-5) from baseline to endpoints between experimental and control conditions. Main outcome parameters for cost-effectiveness are the difference in health-related quality of life (EQ-5D-5L) and costs from a societal perspective (TiC-P) from baseline to endpoints between the experimental and control group.	—

Measure

Time frame

The primary clinical outcome parameter is the difference in response pattern in terms of PTSD symptom severity on the clinical interview (CAPS-5) from baseline to endpoints between experimental and control conditions. Main outcome parameters for cost-effectiveness are the difference in health-related quality of life (EQ-5D-5L) and costs from a societal perspective (TiC-P) from baseline to endpoints between the experimental and control group.

—

Secondary

Measure	Time frame
Symptom complexity (defined as dissociative symptoms, moral injury, complex PTSD symptoms, and comorbid personality traits), comorbidity (depression, anxiety), verbal memory, experiential avoidance, and social support.	—

Countries

Netherlands

Contacts

Public ContactM. J. Mink-Nijdam

ARQ Centrum'45

arqcentrum45@arq.org+31 715 191 500

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)